Philips Allura Xper systems (R8.1 with Poly-G Stand) Interventional Fluoroscopic X-Ray System, Model Numbers 722010, 722
FDA device recall Z-2716-2024 · posted 2024-08-22 · Open, Classified
Recall details
- Recalling firm
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Reason for recall
- A half-threaded bolt was included in the LTE kits instead of the correct full-threaded bolt.
- Action taken
- An URGENT Medical Device Correction notification letter dated 7/31/24 was sent to customers. Actions that should be taken by the customer / user in order to prevent risks for patients. a. Affected systems may continue to be used in accordance with the Instructions for Use (IFU). b. Keep this Urgent Medical Device Correction letter with the documentation of the system until Philips corrects your system. Ensure the letter is in a place likely to be seen/viewed. c. Circulate this notice to all users of the system so that they are aware of the issue. d. Should you experience uncontrolled C-arm movement, call your local Philips representative to report the event. e. Return the attached response form to Philips promptly and no later than 30 days from receipt to confirm that the users of the system have reviewed and understood this Medical Device Correction and required actions to be taken. Actions planned by Philips IGT-S to correct the problem Philips will contact all affected customers to arrange for a Field Service Engineer visit to install an updated Lifetime Extension Kit with the correct full-threaded bolt (reference FCO72200590). If you need any further information or support concerning this issue, contact your local Philips representative at 1-800-722-9377 (Philips Customer Care Solutions Center).
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- OWB
- Quantity affected
- 6 units
- Distribution
- Worldwide - US Nationwide distribution in the states of IL and OR. The countries of Hungary, Ireland, Poland, UK.
- Date initiated
- 2024-08-08
- Date posted
- 2024-08-22
- Location
- Best, Netherlands
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Allura Xper FD series and Allura Xper OR Table series (K161563) | Philips Medical Systems Nederland B.V. | 2016-07-29 |